Events

Retiro De Equipo (Recall) de Pulsar-35 and Pulsar-18 and peripheral self-expanding Nitinol stent systems (with stent length of 200 mm only)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Biotronik Australia Pty Ltd.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    RC-2015-RN-00440-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2015-05-25
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00440-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Notas adicionales en la data
  • Causa
    Biotronik has received a higher than expected number of complaints regarding incomplete stent deployments with specific sizes and lots of our pulsar-18 and pulsar-35 peripheral self-expanding nitinol stent systems. potential health hazards resulting from this type of failure include increased procedure time, vessel wall injury or the need to remove the incompletely deployed stent. stents that have already been implanted are not affected as the issue occurs during deployment of the stent.
  • Acción
    Users are advised to discontinue any further use of the affected stock and remove them from their inventory. A sales representative will contact customers to collect the affected stock. This action has been closed-out on 02/12/2016.

Device

Pulsar-35 and Pulsar-18 and peripheral self-expanding Nitinol stent systems (with stent length of...
  • Modelo / Serial
    Pulsar-35 and Pulsar-18 and peripheral self-expanding Nitinol stent systems (with stent length of 200 mm only) Pulsar-35Product Codes: 379921, 379941, 379926, 379946, 379931, 379951Specific LotsARTG number: 169368 Pulsar-18 Product Codes: 366812, 366832, 366817, 366837, 366822, 366842, 366827, 366847Specific LotsARTG number: 142025
  • Manufacturer
    Biotronik Australia Pty Ltd

Manufacturer

Biotronik Australia Pty Ltd
  • Empresa matriz del fabricante (2017)
    Ms Holding Ii Se
  • Comentario del fabricante
    Biotronik told ICIJ that, when it identifies the need to issue a recall, the company immediately informs physicians of all potentially affected patients. It also noted that product recalls for all manufactures are publically available on the relevant national authorities’ websites. “As soon as an event is deemed serious either by a hospital or a manufacturer, it is reported inter alia to the regulatory authority in the country in which the incidence has occurred, as well as to the FDA for US-approved devices, even if the event has occurred outside of the US,” the company said.
  • Source
    DHTGA